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Cooling Strategies for Hyperthermia in the Elderly
N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how cooling helps reduce heart strain from summer heat waves in elderly people.
Who is the study for?
This trial is for people aged 65 or older who are generally healthy, without significant medical issues based on a thorough check-up. It's not open to those with certain heart problems, a BMI of 31 or higher, chronic conditions needing ongoing treatment, known heart disease, current smokers or those who quit within the last three years.
What is being tested?
The study is looking at how different cooling methods like fans and water sprays can help reduce heat-related cardiovascular stress in elderly individuals during heat waves. Some participants will use just a fan, others just a spray, some both together, and there'll be a control group with no intervention.
What are the potential side effects?
Since this trial involves non-invasive cooling techniques such as fans and water sprays rather than medication or surgery, side effects are minimal but may include discomfort from coldness or skin irritation from prolonged moisture exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in core body temperature
Change in left ventricular function
Secondary study objectives
Arterial blood pressure
Cardiac output
Cerebral perfusion
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Very hot and dryExperimental Treatment4 Interventions
Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, which reflects a very hot and dry heat wave condition similar to the 2018 Los Angeles heat wave. Four visits will be required to complete this arm, with each visit a different cooling modality applied.
Group II: Hot and humidExperimental Treatment4 Interventions
Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, which reflects hot and humid heat wave similar to the 1995 Chicago heat wave. Four visits will be required to complete this arm, with each visit a different cooling modality applied.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,056,114 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.My heart screening showed possible signs of blocked blood flow or a new heart condition.My BMI is 31 or higher.I have a known heart condition.I have a chronic condition like diabetes or high blood pressure that needs regular treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Hot and humid
- Group 2: Very hot and dry
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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